JP2019163318A5 - - Google Patents

Claims (16)

A composition for use in reducing the risk of venous thromboembolism (VTE) associated with the use of a contraceptive method, preferably the use of drospirenone in a contraceptive method, said composition. A composition comprising an effective amount of estetrol. Effective amounts of estetrol for the manufacture of drugs to reduce the risk of venous thromboembolism (VTE) associated with the use of contraceptive methods, preferably the use of drospirenone in contraceptive methods. Use of compositions containing estetrol). The composition further comprises a progestogen component, preferably the progestogenic component is progesterone, desogestrel, gestodene, dienogest, levonorgestrel, Selected from the group consisting of norgestimate, norethisterone, drospirenone, trimegestone, dydrogesterone, precursors of these progestogens and mixtures thereof. , The composition or use for use according to claim 1 or 2. Use according to any one of claims 1 to 3, wherein one or more of the number, frequency and severity of side effects associated with the treatment are reduced as compared to other contraceptive treatments of similar efficacy. Composition or use for. The estetrol component is used in a daily dose of 1 mg to 40 mg, preferably a daily dose of 5 mg to 25 mg, more preferably a daily dose of 10 mg to 20 mg, and even more preferably a daily dose of about 15 mg. The composition or use for use according to any one of claims 1 to 4. The composition or use for use according to any one of claims 3 to 5, wherein the composition further comprises drospirenone. The use according to claim 6, wherein drospirenone is used in a daily dose of 0.5 mg to 10 mg, preferably a daily dose of 1 mg to 4 mg, more preferably about 3 mg daily. Composition or use. The composition for use according to any one of claims 1 to 7, wherein the administration method is a combination of a non-administration interval of about 7 days, preferably a non-administration interval of about 4 days. use. The composition for use according to any one of claims 1 to 8, wherein the estetrol component is estetrol, preferably estetrol monohydrate. use. The composition or use for use according to claim 9, wherein estetrol is used in a daily dose of about 15 mg of estetrol. The composition or use for use according to claim 10, wherein drospirenone is used in a daily dose of about 3 mg. The composition or use for use according to any one of claims 1 to 11, wherein the composition is formulated as an oral unit of administration, preferably the unit of administration corresponding to a daily unit of administration. The composition for use according to claim 12, wherein the estrogen component and the progestogen component, where present, are administered in separate or single dose units. use. The composition or use for use according to any one of claims 1 to 13, wherein the hemostatic change after administration of 1, 2 or 3 cycles does not cross the boundary of the normal range. The composition or use for use according to any one of claims 1-14, wherein the VTE risk is lower than the VTE risk associated with the combination of 20 μg ethinyl estradiol and 3 mg drospirenone. One of claims 1 to 15, wherein the VTE risk is assessed by a surrogate VTE marker, preferably D-dimer, sex hormone-binding globulin (SHBH), protein C activity or protein S activity, more preferably SHBG. Composition or use for use as described in.